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Identification of Outcome Predictors and Stratification of Responder Profiles Implanted With Spinal Cord Stimulation. An AI-based-pathway & Algorithmic Approach to Treat Failed Back Surgery Syndrome Patients (PREDIBACK 2)

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ClinicalTrials.gov Identifier: NCT04587674
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : June 13, 2022
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:

Failed Back Surgery Syndrome is commonly defined as new, recurrent, or persistent pain in the back and/or leg(s) of at least 6-month duration following spinal surgery. The literature estimates that 10-50% of patients undergoing spinal surgery are likely to develop such pain, representing a substantial financial burden. Among them, 5-10% would suffer from severe pain, which are intense, neuropathic and generally refractory to conventional therapeutic strategies considerably affect patients' functional capacity as well as their psychological and social well-being.

Spinal Cord Stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain such as FBSS. SCS is a safe and reversible treatment option, which leads to improvement in pain relief and quality of life for patients with FBSS. Despite encouraging results in a chronic painful patient population that is refractory to conventional therapies, the literature estimates that only 58% [53% - 64%] of patients implanted with SCS devices achieved adequate pain relief.

FBSS population characterization and stratification and predictive modeling of SCS outcome are thus crucial to delineate future treatment options and to deliver neuromodulation therapy to the right patient.

The investigators designed a clinical prospective project based on SCS outcome optimization and SCS candidates' stratification: PREDIBACK 2.

This study would be a following part of a continuous project (PREDIBACK) that aims to better understand and stratify the therapies (drugs, surgery, psychological therapy or SCS) proposed to FBSS patients. The goal of PREDIBACK 1 was to develop a decision tool that simplifies the therapeutic decision process.

PREDIBACK 2 will focus on the neuromodulation pathway. Easing and helping patient orientation should improve referral yielding to specialists and accelerate patient flow through care pathway. Hence, facilitating access to adequate therapies for FBSS patients who usually have a longstanding history of pain.


Condition or disease Intervention/treatment Phase
Pain, Intractable Device: Spinal Cord Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Identification of Outcome Predictors and Stratification of Responder Profiles Implanted With Spinal Cord Stimulation. An AI-based-pathway & Algorithmic Approach to Treat Failed Back Surgery Syndrome Patients
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Spinal Cord Stimulation Device: Spinal Cord Stimulation
Lead(s) and Implant Pulse Generator




Primary Outcome Measures :
  1. Composite SCS efficacy score [ Time Frame: 6 months ]

    Rate of SCS responders is defined as having at least three of these criteria:

    • Having at least a 30% decrease in Oswestry Disability Index (ODI) percentage. 10 items ranging from 0 to 5 where 0 indicates high ability and 5 indicate the inability.
    • Having at least a 50% decrease in the Visual Analogic Scale (VAS) (0 = no back pain, 10=worst imaginable pain)
    • Having at least a 0.2 points increase in the EuroQol-5 Dimensions (EQ-5D) questionnaire score. The maximum score of 1 indicates the best possible quality of life.
    • Having a decrease of 1.4 points in the Hospital Anxiety-Depression Scale (HADS) score. The total score ranges from 0 to 24 for each category.
    • 30% decrease pain surface (cm²): pain will assess painful area in terms of intensity, surface and pain typology.
    • Having a Patient Global Impression of Change (PGIC) score of at least 6. PGIC is a 7-point scale.
    • Drug intake will be measured using the Medication Quantification Scale (MQS) with a reduction of 3.4 points.


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 6 months ]
    Pain intensity will be assessed using the Visual Analogic Scale (VAS score : 0 "no pain" to 10 "worst pain")

  2. Pain surface [ Time Frame: 6 months ]
    Pain mapping criteria will be compared. Pain mapping criteria include: Global Pain Surface (cm²), Pain intensities associated with the surface measurements, Mechanical/neuropathic components of pain surfaces.

  3. Functional capacity [ Time Frame: 6 months ]
    Functional capacity will be assessed using the Oswestry Disability Index (ODI, 0 "no disability" to 100% "complete disability")

  4. Impact of Quality of life [ Time Frame: 6 months ]
    Quality of life will be assessed using the EuroQol Five Dimensions index (EQ5D, 0 "dead" to 1 "perfect health")

  5. Psychological distress [ Time Frame: 6 months ]
    Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS, For each subscale the total score is at most 21. A score of ≥11 is considered a clinically significant disorder)

  6. Social insecurity [ Time Frame: 6 months ]
    Social insecurity will be assessed using the EPICES questionnaire [0 = low risk of insecurity to 100 = high risk of insecurity]

  7. Psychological resilience [ Time Frame: 6 months ]
    Psychological resilience will be assessed using the CD-RISC-10 (10-item Connor-Davidson Resilience Scale) questionnaire. [0 = low resilience to 40 = high resilience]

  8. Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia [ Time Frame: 6 months ]
    % of Type of lead (Spinal Cord Stimulation Monocolumn vs Multicolumn Lead)

  9. Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia [ Time Frame: 6 months ]
    Stimulation intensity (mA, milliAmper)

  10. Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia [ Time Frame: 6 months ]
    Stimulation pulse width (µs, microsecond)

  11. Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia [ Time Frame: 6 months ]
    Stimulation frequency (Hz, Hertz)

  12. Effects of the technical parameters and Spinal Cord Stimulation devices on paresthesia [ Time Frame: 6 months ]
    % of Stimulation Waveform (Low Dose, High Dose, Both), Electrical parameters

  13. Spinal Cord Stimulation efficacy using objective measurement tools [ Time Frame: 6 months ]

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Duration of standing position given by both Intellis and GT9X,


  14. Spinal Cord Stimulation efficacy using objective measurement tools [ Time Frame: 6 months ]

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Duration of sitting position given by both Intellis and GT9X,


  15. Spinal Cord Stimulation efficacy using objective measurement tools [ Time Frame: 6 months ]

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Duration of lying position given by both Intellis and GT9X,


  16. Spinal Cord Stimulation efficacy using objective measurement tools [ Time Frame: 6 months ]

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Duration of mobile position (activity) given by both Intellis and GT9X,


  17. Spinal Cord Stimulation efficacy using objective measurement tools [ Time Frame: 6 months ]

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Number of steps given by GT9X,


  18. Spinal Cord Stimulation efficacy using objective measurement tools [ Time Frame: 6 months ]

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Sleep duration given by GT9X,


  19. Spinal Cord Stimulation efficacy using objective measurement tools [ Time Frame: 6 months ]

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Sleep efficacy given by GT9X,


  20. Spinal Cord Stimulation efficacy using objective measurement tools [ Time Frame: 6 months ]

    Intellis/SnapshotTM platform to the ActiGraph GT9X.

    -Sleep onset latency given by GT9X,




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Selection Criteria:

  • Subject is ≥ 18 years and ≤ 80 years.
  • Subject has FBSS and does not require further surgery. For the purpose of this study, FBSS is defined as persistent or recurrent low back and leg pain of at least 6-month duration following at least one decompression and/or fusion procedure.
  • Subject has persistent low back and leg pain despite other treatment modalities (pharmacological, surgical, physical, or psychological therapies) that have been tried and did not prove satisfactory or are unsuitable or contraindicated for the subject.
  • VAS global pain is ≥ 50 mm.
  • Subject meets the criteria for spinal cord stimulation test according to HAS guidelines (multidisciplinary consultation, psychological assessment...).
  • Absence of active psychosis or history of serious psychotic illness requiring hospitalization.
  • Subject understands and accepts the constraints of the study.
  • Patient covered by French national health insurance.
  • Patient who has given written consent to the study after having received clear information.

Non-inclusion Criteria:

  • Subject is or has been treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the localization related to his/her original back pain complaint or experimental therapies.
  • Subject low back pain is coming from a non-FBSS etiology (i.e. cancerous pain, infectious disease, etc.).
  • Cause of low back pain accessible to etiological "mechanical" surgical treatment (discogenic low back pain, vertebral instability, spinal deformity, etc.).
  • Subject had most recent back surgery less than 6 months ago.
  • Simultaneous participation to any interventional study during the study
  • Subject requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patient in an emergency setting.

    • MRI contraindications if MRI is not available within a time frame of 2 years from the last spinal surgery. Absolute contraindications are: Cardiac implantable electronic device, metallic intraocular foreign bodies, cochlear implants, drug infusion pumps, catheters with metallic components, cerebral artery aneurysm clips, magnetic dental implants, tissue expander, artificial limb, hearing aid, piercing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587674


Contacts
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Contact: Manul ROULAUD, MSc +33 5 49 44 32 23 manuel.roulaud@chu-poitiers.fr

Locations
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France
Parc Polyclinic Not yet recruiting
Caen, France, 14052
Contact: Violaine D'ANS, MD       violaine.dans@orange.fr   
Principal Investigator: Violaine D'ANS, MD         
Louis Pasteur Hospital Recruiting
Colmar, France, 68000
Contact: Jimmy VOIRIN, MD    03.89.12.42.07    jimmy.voirin@ch-colmar.fr   
Principal Investigator: Jimmy VOIRIN, MD         
Lyon University Hospitals Not yet recruiting
Lyon, France, 69500
Contact: Manon DURAFFOURG, MD       manon.duraffourg@yahoo.fr   
Principal Investigator: Manon DURAFFOURG, MD         
Nice University Hospital, Cimiez Hospital Recruiting
Nice, France, 06000
Contact: Denys FONTAINE, MD, PhD    04 92 03 85 03    fontaine.d@chu-nice.fr   
Principal Investigator: Denys FONTAINE, MD, PhD         
Sub-Investigator: Aurélie LEPLUS WUERTZER, MD         
Sub-Investigator: Michel LANTERI-MINET, MD         
Sub-Investigator: Emilie PIQUET-RAYNAUD, MD         
Poitiers Hospital University Recruiting
Poitiers, France, 86021
Contact: Véronique FERRAND-RIGALLAUD    +33 5 49 44 46 65    Veronique.FERRAND-RIGALLAUD@chu-poitiers.fr   
Principal Investigator: Philippe RIGOARD, MD, PhD         
Foch Hospital Not yet recruiting
Suresnes, France, 92151
Contact: Marie-Christine DJIAN, MD    01 46 25 19 22    mc.djian@hopital-foch.com   
Principal Investigator: Marie-Christine DJIAN, MD         
Sponsors and Collaborators
Poitiers University Hospital
Investigators
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Principal Investigator: Philippe RIGOARD, MD, PhD Poitiers Hospital Unoversity
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT04587674    
Other Study ID Numbers: 2020-A01734-35
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Failed Back Surgery Syndrome
Pain, Intractable
Postoperative Complications
Pathologic Processes
Back Pain
Pain
Neurologic Manifestations